Work Item
ASTM WK64938

New Practice for the Calculation of Cleaning Validation Limits

1. Scope

Pharmaceuticals, Biopharmaceuticals, Nutraceuticals, Cosmetics and Medical Devices

Keywords

Cleaning, Cleaning Validation, Acceptance Limit, Maximum Safe Carryover, MSC, Total Organic Carbon, TOC, Visual Residue Limit, VRL Visual Inspection, Process Capability, Statistical Process Control, SPC

Rationale

This standard will be used to provide guidance on implementing the E3106-18 Standard Guide Science-Based and Risk-Based Cleaning Process Development and Validation and for the E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs)

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E55.03

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 08-24-2018

Technical Contact: Andrew Walsh

Item: 000

Ballot:

Status: